Do Parkinson’s disease patients disclose their adverse events spontaneously?

• Published in: European journal of clinical pharmacology Vol. 68; no. 5; pp. 857 - 865
• Main Authors: Perez-Lloret, Santiago, Rey, María Verónica, Fabre, Nelly, Ory, Fabienne, Spampinato, Umberto, Montastruc, Jean-Louis, Rascol, Olivier
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.05.2012; Springer; Springer Nature B.V
• Subjects: Age; Aged; Anticonvulsants. Antiepileptics. Antiparkinson agents; Antiparkinson Agents - adverse effects; Antiparkinson Agents - therapeutic use; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Clinical trial. Drug monitoring; Cross-Sectional Studies; Data collections; Disclosure; Drug Monitoring; Drug therapy; Drug toxicity and drugs side effects treatment; Drugs; Epidemiology; Female; France; General pharmacology; Hospitals, University; Humans; Interviews as Topic; Inventories; Male; Medical sciences; Miscellaneous (drug allergy, mutagens, teratogens...); Movement disorders; Neurodegenerative diseases; Neuropharmacology; Outpatient Clinics, Hospital; Parkinson Disease - drug therapy; Parkinson's disease; Pharmacoepidemiology and Prescription; Pharmacology; Pharmacology. Drug treatments; Pharmacology/Toxicology; Sex; Side effects; Surveys and Questionnaires; France; Motor fluctuations; Underreporting; Pharmacological treatment; Dopamine agonists; Non-motor symptoms; Adverse drug reactions; Levodopa; Parkinson’s disease; Agonist; Parkinson's disease; Toxicity; Motor system disorder; Parkinson disease; Pharmacotherapy; Secondary effect; Degenerative disease; Neurological disorder; Human; Drug; Nervous system diseases; Fluctuations; Antiparkinson agent; Cerebral disorder; D2 Dopamine receptor; Treatment; Central nervous system disease; Dopamine agonist; Extrapyramidal syndrome
• ISSN: 0031-6970; 1432-1041
• DOI: 10.1007/s00228-011-1198-x

Background Underreporting of adverse drug reactions is common but has been rarely studied in Parkinson’s disease (PD). Objective To compare the prevalence of adverse events (AEs) in relation to antiparkinsonian drugs in PD patients using two different data collection methods: patient’s spontaneous reporting versus a predefined investigator-driven structured interview. Secondary objectives were to assess factors related to spontaneous reporting and to compare the rate of AE reporting in PD patients with that of a group of non-parkinsonian post-stroke patients. Study design Cross-sectional study. Patients Ambulatory, cognitively intact PD or post-stroke outpatients. Interventions None. Outcome measures Patients were first asked by means of an an open question to disclose any unpleasant effects in connection with their current medications that had occurred during the previous week. Afterwards, a predefined questionnaire listing the most common AEs known to be related to antiparkinsonian drugs was used to question the same patients in a systematic manner about the presence of any AE during the same week. Chronological and semiological criteria were used to classify the reported AEs as “unrelated” or “possibly/plausibly related” to the antiparkinsonian treatment. Results A total of 203 PD and 52 post-stroke patients of comparable age and sex were recruited. Eighty-five PD and five post-stroke patients reported spontaneously at least one AE (42 vs. 10%, p  < 0.01), while 203 PD and 47 post-stroke patients reported at least one AE following the structured questionnaire (100 vs. 90%, p  < 0.001). In PD patients, there were a total of 112 spontaneously reported AEs as compared with 1,574 according to the structured questionnaire (7%). Spontaneous disclosure of AEs was associated with experiencing >2 AEs [OR = 1.2 (1.1–3.2)], logistic regression). Seventy-four percent of PD patients had ≥1 AE possibly/plausibly related to antiparkinsonian drugs. Conclusions Results showed that only 7% of AEs were reported spontaneously by patients, thus underscoring the importance of systematically asking about AEs in PD patients.